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BioWorld - Sunday, May 17, 2026
Home » Topics » Medical technology

Medical technology
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Regulatory actions for May 4, 2021

May 4, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobeat, Lifespine, Purigen, Santen, Standard Bariatrics.
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Other news to note for May 4, 2021

May 4, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Avisa, Flurotest, Ivenix, Ivwatch, Moleculight, Premier, Sentinel Diagnostics, Smiths Medical, Vizient.
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In the clinic for May 4, 2021

May 4, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Fineheart, Inecure.
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Financings for May 4, 2021

May 4, 2021
Med-tech firms raising money in public or private financings, including: Confluent Medical Technologies, Cumulus Neuroscience, Electrospinning.
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Appointments and advancements for May 4, 2021

May 4, 2021
New hires and promotions in the med-tech industry, including: Carta Healthcare, Dexcare, Intersect ENT, Clarius Mobile, Pentax.
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Arthritis pain illustration

Labcorp seeks to dominate rheumatoid arthritis testing with Vectra purchase from Myriad Genetics

May 3, 2021
By Annette Boyle
Laboratory Corporation of America Holdings (Labcorp) further consolidated its position as a leading provider of rheumatoid arthritis testing with a definitive agreement to acquire the Vectra assay from Myriad Genetics Inc. along with other assets of the Salt Lake City-based company’s autoimmune business unit in a deal valued at $150 million in cash. The transaction is expected to close by the end of the third quarter of 2021.
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Illustration of TAVR device

Study claims TAVR center locations have done little to improve rural access

May 3, 2021
By Mark McCarty
The history of Medicare coverage of transcatheter aortic valve replacement (TAVR) devices has not lacked for controversy despite the massive positive impact on outcomes. Ashwin Nathan, of Hospital of the University of Pennsylvania, said a new analysis made clear that the expansion of centers qualified to perform TAVR procedures has been nearly all in high population density areas with an existing TAVR program, thus leaving out the still-forgotten rural patient.
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Molli Surgical magnetic breast tumor marking device

FDA clears Molli Surgical’s magnetic breast tumor marking device

May 3, 2021
By Meg Bryant
Molli Surgical Inc. has won the FDA’s nod for its wire-free localization technology for breast cancer surgery. The company said the Molli system helps radiologists tag cancerous lesions quickly and precisely, facilitating surgical excision and eliminating a source of anxiety associated with breast tumor removal.
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Phlebotomist draws blood from patient

Celltrion wins European approval for ELISA COVID-19 test kit

May 3, 2021
By Gina Lee
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
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Biotech first: EC fines company over M&A divestiture info

May 3, 2021
By Mari Serebrov
In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation.
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